Artificial Intelligence/Machine Learning-Based Software as a Medical Device Action Plan

This AI/ML-Based Software as a Medical Device Action Plan was developed in direct response to the stakeholder feedback described herein, and it builds on the Agency’s longstanding commitment to support innovative work in the regulation of medical device software and other digital health technologies. In order to continue to advance the concepts from the AI/ML discussion paper toward a practical oversight of AI/ML-based SaMD and of the field in general, the Agency has updated the plan.